Primary Ciliary DyskinesiaNCT05040607
Physical Fitness, Exercise Capacity and Activities of Daily Living in Primary Ciliary Dyskinesia: a Retrospective Study
An observational study of Primary Ciliary Dyskinesia and Kartagener Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Decreased pulmonary function, peripheral muscle strength, and exercise capacity were reported in primary ciliary dyskinesia (PCD) in recent studies. We aimed to investigate the data conducted between 10 July 2015 and 10 January 2015 of pulmonary function, respiratory muscle strength, exercise capacity, physical… Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Ciliary Dyskinesia, Kartagener Syndrome, Immotile Cilia Syndrome
- What is being tested?
- Data Collection
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2020to 10 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patient group: PCD patients consulted from Hacettepe University, Faculty of Medicine, Department of Pediatric Chest Diseases, Child Health and Diseases/, Ankara, Turkey to our unit for evaluation in terms of respiratory physiotherapy were included in our study. Healthy group: Healthy counterparts from our database of the previous studies were included in our study.
Who may be able to join
- Clinically stable
- Being able to cooperate with the assessments
- Not having any orthopedic, or neurological problems
Who cannot join
- Not being clinically stable
- Not being able to cooperate with the assessments
- Having any orthopedic, or neurological problems
Trial locations and contacts
1 site in 1 country.
About this study
Decreased pulmonary function, peripheral muscle strength, and exercise capacity were reported in primary ciliary dyskinesia (PCD) in recent studies. We aimed to investigate the data conducted between 10 July 2015 and 10 January 2015 of pulmonary function, respiratory muscle strength, exercise capacity, physical fitness, and activities of daily living (ADL) in PCD and healthy counterparts retrospectively at the first stage of the study and the effects of inspiratory muscle training on pulmonary function, respiratory muscle strength, and exercise capacity in PCD patients with decreased inspiratory muscle strength from the database recorded between 10 July 2015 and 10 January 2015 retrospectively at the second stage of the study.
- Being tested
- Data Collection
- Keywords
- Primary Ciliary Dyskinesia, Kartagener Syndrome, Immotile Cilia Syndrome, Pulmonary Function, Respiratory Muscle Strength, Exercise Capacity, Physical Fitness, Inspiratory Muscle Strength Training
- Medical subject headings
- Ciliary Motility Disorders, Kartagener Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
The first stage of the study:
Retrospective data collection of pulmonary function, respiratory muscle strength, exercise capacity, physical fitness, and activities of daily living (ADL).
The second stage of the study
-Retrospective data of pulmonary function, respiratory muscle function, functional capacity before and after supervised inspiratory muscle training with POWERbreathe K5 device using tapered flow resistive loading and airway clearance techniques performed for 6 weeks in PCD with decreased respiratory muscle strength.
Data CollectionOther
-Retrospective data collection of pulmonary function, respiratory muscle function, exercise capacity, physical fitness, and activities of daily living (ADL).
| Study group | Role | What they receive |
|---|---|---|
| Primary Ciliary Dyskinesia (PCD) | The first stage of the study:
Data of 20 PCD patients from the database recorded between 10 July 2015 and 10 January 2017.
The second stage of the study:
-Data of 14 PCD patients who had lower inspiratory muscle strength from the same database underwent supervised inspiratory muscle training (IMT) with tapered flow resistive loading using Powerbreathe K5 device at our research unit and airway clearance techniques (ACT) as a home-based therapy for 6 weeks from the database recorded between 10 July 2015 and 10 January 2017. Receives: Other: Data Collection | |
| Healthy Group | Data of 20 healthy subjects from the database recorded between 10 July 2015 and 10 January 2017. Receives: Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
A primer outcome for the first stage of the study: Physical fitness
Munich Physical Fitness Test (MFT) was used to evaluate physical fitness. It is a test with six parameters including ball bounce, sandbag throwing, bending, vertical jumping, hanging and step test.
Measured: 10 July 2015-10 January 2015-retrospectively
A primer outcome for the second stage of the study: Functional capacity
Functional capacity was evaluated with six minute walk test (6MWT).
Measured: 10 July 2015-10 January 2015-retrospectively
Secondary outcomes (8)
Demographic features
The age was recorded in years.
Measured: 10 July 2015-10 January 2015-retrospectively
Demographic features
Weight was recorded in kilograms.
Measured: 10 July 2015-10 January 2015-retrospectively
Demographic features
The length was saved in meters.
Measured: 10 July 2015-10 January 2015-retrospectively
Demographic features
Body mass index was calculated by dividing the weight by the square of the height (kg/m^2) and recorded.
Measured: 10 July 2015-10 January 2015-retrospectively
Pulmonary Function
Pulmonary function (FEV1 (forced expiratory volume in one second), FVC (forced vital capacity), FEV1/FVC, FEF25-75 (%) (forced expiratory volume 25-75 %) and PEF (peak expiratory flow)) assessed with a portable spirometer (Spirobank MIR, Italy).
Measured: 10 July 2015-10 January 2015-retrospectively
Respiratory muscle functions
Respiratory muscle strength (maximal inspiratory pressure (MIP);maximal expiratory pressure (MEP), respectively) was measured with a portable, electronic mouth pressure monitor (Micro Medical MicroMPM, UK) and recorded.
For second stage of the study; average inspiratory flow, inspiratory volume, and inspiratory work was evaluated based on the outcomes of the Breathe-Link software using POWERbreathe K5 device before and after IMT with tapered flow resistive loading and recorded.
Measured: 10 July 2015-10 January 2015-retrospectively
Exercise Capacity
Exercise capacity was assessed with the modified shuttle walk test.
Measured: 10 July 2015-10 January 2015-retrospectively
Activities of Daily Living
Glittre activities of daily living (ADL) test was used to evaluate daily life activity.
Measured: 10 July 2015-10 January 2015-retrospectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start21 Jan 2020
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ciliary DyskinesiaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazal Sonbahar Ulu, Hacettepe University
- Investigators
- Hazal Sonbahar Ulu, MSc, Principal investigator, Hacettepe UniversityDeniz Inal Ince, Prof. Dr., Study chair, Hacettepe UniversityDeniz Inal Ince, Prof. Dr., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040607
- Sponsor's protocol ID
- GO 19/730
- Status last verified
- Apr 2023
- First submitted
- 24 Aug 2021
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Fitness, Exercise Capacity and Activities of Daily Living in Primary Ciliary Dyskinesia: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05040607
- Acronym / sponsor ID
- GO 19/730
- Keywords
- Primary Ciliary Dyskinesia, Kartagener Syndrome, Immotile Cilia Syndrome, Pulmonary Function, Respiratory Muscle Strength, Exercise Capacity, Physical Fitness, Inspiratory Muscle Strength Training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Decreased pulmonary function, peripheral muscle strength, and exercise capacity were reported in primary ciliary dyskinesia (PCD) in recent studies. We aimed to investigate the data conducted between 10 July 2015 and 10 January 2015 of pulmonary function, respiratory muscle strength, exercise capacity, physical fitness, and activities of daily living (ADL) in PCD and healthy counterparts retrospectively at the first stage of the study and the effects of inspiratory muscle training on pulmonary function, respiratory muscle strength, and exercise capacity in PCD patients with decreased inspiratory muscle strength from the database recorded between 10 July 2015 and 10 January 2015 retrospectively at the second stage of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Ciliary Dyskinesia (PCD) | – | Other: Data CollectionThe first stage of the study: Data of 20 PCD patients from the database recorded between 10 July 2015 and 10 January 2017. The second stage of the study: -Data of 14 PCD patients who had lower inspiratory muscle strength from the same database underwent supervised inspiratory muscle training (IMT) with tapered flow resistive loading using Powerbreathe K5 device at our research unit and airway clearance techniques (ACT) as a home-based therapy for 6 weeks from the database recorded between 10 July 2015 and 10 January 2017. |
| Healthy Group | – | Other: Data CollectionData of 20 healthy subjects from the database recorded between 10 July 2015 and 10 January 2017. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patient group: PCD patients consulted from Hacettepe University, Faculty of Medicine, Department of Pediatric Chest Diseases, Child Health and Diseases/, Ankara, Turkey to our unit for evaluation in terms of respiratory physiotherapy were included in our study. Healthy group: Healthy counterparts from our database of the previous studies were included in our study.
Key inclusion criteria (3 listed)
- Clinically stable
- Being able to cooperate with the assessments
- Not having any orthopedic, or neurological problems
Key exclusion criteria (3 listed)
- Not being clinically stable
- Not being able to cooperate with the assessments
- Having any orthopedic, or neurological problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data CollectionThe first stage of the study: Retrospective data collection of pulmonary function, respiratory muscle strength, exercise capacity, physical fitness, and activities of daily living (ADL). The second stage of the study -Retrospective data of pulmonary function, respiratory muscle function, functional capacity before and after supervised inspiratory muscle training with POWERbreathe K5 device using tapered flow resistive loading and airway clearance techniques performed for 6 weeks in PCD with decreased respiratory muscle strength. | Other | Primary Ciliary Dyskinesia (PCD) |
| Data Collection-Retrospective data collection of pulmonary function, respiratory muscle function, exercise capacity, physical fitness, and activities of daily living (ADL). | Other | Healthy Group |
Primary outcome
A primer outcome for the first stage of the study: Physical fitness
Time frame: 10 July 2015-10 January 2015-retrospectively
Munich Physical Fitness Test (MFT) was used to evaluate physical fitness. It is a test with six parameters including ball bounce, sandbag throwing, bending, vertical jumping, hanging and step test.
A primer outcome for the second stage of the study: Functional capacity
Time frame: 10 July 2015-10 January 2015-retrospectively
Functional capacity was evaluated with six minute walk test (6MWT).
8 secondary outcomes
Demographic features
Time frame: 10 July 2015-10 January 2015-retrospectively
Demographic features
Time frame: 10 July 2015-10 January 2015-retrospectively
Demographic features
Time frame: 10 July 2015-10 January 2015-retrospectively
Demographic features
Time frame: 10 July 2015-10 January 2015-retrospectively
Pulmonary Function
Time frame: 10 July 2015-10 January 2015-retrospectively
Respiratory muscle functions
Time frame: 10 July 2015-10 January 2015-retrospectively
Exercise Capacity
Time frame: 10 July 2015-10 January 2015-retrospectively
Activities of Daily Living
Time frame: 10 July 2015-10 January 2015-retrospectively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hazal Sonbahar Ulu, MSc principal investigator
Hacettepe University
Deniz Inal Ince, Prof. Dr. study chair
Hacettepe University
Deniz Inal Ince, Prof. Dr. study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Ciliary Dyskinesia and Kartagener Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A primer outcome for the first stage of the study: Physical fitness (time frame: 10 July 2015-10 January 2015-retrospectively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.